Treatment Landscape and Real-World Dosing Patterns With CDK4/6 Inhibitors for Breast Cancer in Portugal
- Conditions
- Breast Cancer
- Registration Number
- NCT07223476
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
Assess and characterize the real-world cyclin-dependent kinase 4/6 inhibitor (CDKI) use in advanced/metastatic breast cancer (a/mBC), evaluate treatment persistence, and quantify CDKI dose adjustments in Portugal.
This study used secondary data from the IQVIA database that collects data from hospital drug consumption. The study included 16 public hospitals across Portugal, for which data on consumption of drugs used in hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) a/mBC treatment was available. Patient selection was based on a set of criteria considering all patients with treatments in the a/mBC setting with use of at least one CDKI from November 2018 to May 2023.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1926
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Patients Treated With a CDKI Between November 2018 and May 2023 Up to approximately 4 years and 6 months Median Treatment Duration Up to approximately 4 years and 6 months Median Time to Next Treatment (TTNT) Up to approximately 4 years and 6 months TTNT was calculated considering the time between the start of one treatment line and the start of the next treatment line.
Number of Patients With Dose Reductions by Treatment Length per Line of Treatment Up to approximately 4 years and 6 months Patients were categorized as having 0, 1, or 2 dose reductions over 0-6 months, 7-12 months, and 12 months or more of treatment.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Novartis
🇺🇸East Hanover, New Jersey, United States
Novartis🇺🇸East Hanover, New Jersey, United States
